RLS-0071 for newborns with moderate or severe HIE
Part of Brain & nervous system, Genetic & congenital, Heart & circulation clinical trials.
This trial studies whether RLS-0071 is safe and can help some newborns with moderate or severe hypoxic-ischemic encephalopathy (HIE), a brain injury caused by low oxygen around birth. Babies in the study also receive standard whole-body cooling (therapeutic hypothermia), and the researchers will watch for side effects and early signs of benefit.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Born at 36 weeks or later (not extremely premature).
- Had a serious birth event or sudden fetal status change right before/during delivery that could explain the newborn’s poor condition.
- Meet criteria for moderate or severe HIE, such as very abnormal early blood tests, a very low 10-minute Apgar score, needing breathing help for at least 10 minutes, and/or seizures.
- Must be able to start whole-body cooling before 6 hours of age (passive cooling is allowed first).
- Pregnancy was a single baby (not twins or more).
- Parent/legal guardian can sign consent, and the baby can start the first dose within 10 hours of life.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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